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Sarns™ Modular Perfusion System 8000

Primary DI
00886799001721
Brand
Sarns™ Modular Perfusion System 8000
Company
Terumo Cardiovascular Systems Corporation
Model
7278
Catalog number
7278
Device description
"Lamp Long 33"""
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DSJAlarm, Blood-Pressure
DSKComputer, Blood-Pressure
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass
DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
DWAControl, Pump Speed, Cardiopulmonary Bypass
DWBPump, Blood, Cardiopulmonary Bypass, Roller Type
DWCController, Temperature, Cardiopulmonary Bypass
KRIAccessory Equipment, Cardiopulmonary Bypass
KRLDetector, Bubble, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSJAlarm, Blood-PressureCardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DTQConsole, Heart-Lung Machine, Cardiopulmonary BypassCardiovascular2
DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary BypassCardiovascular2
DWAControl, Pump Speed, Cardiopulmonary BypassCardiovascular2
DWBPump, Blood, Cardiopulmonary Bypass, Roller TypeCardiovascular2
DWCController, Temperature, Cardiopulmonary BypassCardiovascular2
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1
KRLDetector, Bubble, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960916000SAMS 8000 CARDIOPLEGIA MONITOR3M Health Care, Sarns1996-06-04DSJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886799001721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886799001721008867990017218867990017210886799001721

GMDN Terms#

Term, Definition table
TermDefinition
Desk mountA non-dedicated (general-purpose) manually-operated structure designed to be fixed to a desk or a worktop and onto which another medical device (not included) is intended to be safely affixed or mounted. This device is typically clamped (i.e., removable) or permanently screwed to the desk or a worktop surface.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177655466
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00699753531932Cardiovascular Procedure Kit78044-012024-07-02
00699753531567Cardiovascular Procedure Kit72149-022024-05-29
00699753531574Cardiovascular Procedure Kit77742-012024-05-29
00699753517721Cardiovascular Procedure Kit75410-022022-10-19
00699753538177Cardiovascular Procedure Kit76754-012026-10-22
00699753538184Cardiovascular Procedure Kit788202026-10-22
00699753538191Cardiovascular Procedure KitCX-UK7722026-10-22
00699753538061Cardiovascular Procedure KitCX-CZ227X2026-10-09
00699753538078Cardiovascular Procedure KitCX-CZ2282026-10-09
00699753538085Cardiovascular Procedure KitCX-SP296X2026-10-09
00699753538092Cardiovascular Procedure KitCX-SP297X2026-10-09
00699753538108Cardiovascular Procedure Kit787582026-10-09
00699753538115Cardiovascular Procedure Kit788232026-10-09
00699753538122Cardiovascular Procedure Kit787472026-10-09
00699753538139Cardiovascular Procedure Kit787482026-10-09
00699753538146Cardiovascular Procedure Kit787442026-10-09
00699753538153Cardiovascular Procedure Kit787462026-10-09
00699753538160Cardiovascular Procedure Kit787452026-10-09

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